StressNCT04964102
Associations of Communication Skills Workshop and Improvements in Stress, Burnout and Empathy and Psychometric Properties of Chinese Version of Perceived Stress Scale, Professional Fulfillment and Burnout Scale and Empathy Among Health Care Professionals
A study testing Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills in people with Stress, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness and empathy level using data collected in pre and post assessments from "Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills". Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2020to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 20 and 65 years old
- willing to attend the workshop and willing to participate this study
Who cannot join
- age less than 20 or over 65 years old
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness and empathy level using data collected in pre and post assessments from "Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills".
Read the detailed description
The medical community is paying more and more attention to the nature of burnout, physiological, or physical stress of health care professionals (HCP). Burn out and stress not only affects the HCP themselves, but subsequently their team members, medical institutions, and patients. Recent research has found that HCP's stress, burnout, and dissatisfaction with work are associated with their practice time and leaving the job; as well as declines in quality of care, poor patient results, and medical errors.
There seems to be a two-way correlation between burn out and empathy. On the one hand, the more burn out, the lower the degree of empathy; on the other hand, the deficits in perspective substitution seems to be a risk factor for burn out. The increase in multiple perspectives and empathic attention seems prevent burn out. Other studies found that practicing clinical communication skills through practices and role-plays, and using emotional regulation methods to enable participants to express their attitudes and feelings about communicating difficult problems may help HCP improve their degree of empathy and communication skills. When such communication courses add combinations of stress management and social skills training can not only improve communication skills, increase empathy, but also prevent burnout and exhaustion.
Therefore, this study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness, and empathy level using data collected in pre- and post- assessments from 'Workshops of Enhancing Interpersonal Effectiveness, Emotional Regulation, and Clinical Communication Skills'. Before and after the workshop, information regarding HCP's burn out, perceived stress, empathy level, and interpersonal effectiveness will be assessed in order to understand whether the workshop has reached its goals and teaching effectiveness. All information regarding personal data will be de-identified and encrypted. These assessments are designed to evaluate the effectiveness of teaching activities in a general teaching environment. This study will also focus on the reliability and validity analysis of the short form research measures which used. It will conduct validation studies comparing the Chinese version of the measures which used with internationally well known but long research measures to make sure the reliability and validity. If these shorter forms have well validity, it may be able to use the short and simplified questionnaires for related research in the future.
- Conditions
- Stress
- Being tested
- Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills
- Keywords
- Professional burn out, Communication skills, empathy, fulfillment
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication SkillsBehavioural
Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills
| Study group | Role | What they receive |
|---|---|---|
| Workshop | Experimental | Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills Receives: Behavioral: Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS) Score before and after workshop and Week 24 Assessed
The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.
Measured: Before and after workshop and 24 weeks
Secondary outcomes (11)
Differences in Empathy Scale before and after workshop and Week 24 Assessed
The Empathy Scale is one of the first measures to achieve widespread use, contains four separate dimensions: social self-confidence, even-temperedness, sensitivity, and nonconformity. The instrument is scored on a scale of 0 (being the least empathetic possible) to 80 (being the most empathetic possible).
Measured: Before and after workshop and 24 weeks
Differences in Insomnia Severity index (ISI) before and after workshop and Week 24 Assessed
The ISI is a rating tool used to gauge of sleeping. Higher values represent a worse outcome.
Measured: Before and after workshop and 24 weeks
Differences in the State and Trait Anxiety Index (STAI) before and after the workshop and Week 24 Assessed
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Before and after workshop and 24 weeks
Differences in Generalized Anxiety Disorder 7-item (GAD-7) before and after the workshop and Week 24 Assessed
Self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. It can also be used as a screening measure of panic, social anxiety, and PTSD. It was modeled after the PHQ9 to be used quickly and effectively within a primary care setting.
Measured: Before and after workshop and 24 weeks
Differences in Patient Health Questionnaire-9 (PHQ-9) before and after the workshop and Week 24 Assessed
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Measured: Before and after workshop and 24 weeks
Differences in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) before and after the workshop and Week 24 Assessed
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF; Endicott et al,1993). The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
Measured: Before and after workshop and 24 weeks
Differences in Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) before and after the workshop and Week 24 Assessed
Differences in Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) may have coped with stressful events in life. The Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) is a 59-item self-report scale designed to assess participants' use of DBT skills (e.g., acceptance, cognitive reappraisal, problem-solving) and maladaptive coping responses. The DBT-WCCL is a checklist designed to gauge ways of coping. As subjects go through the 59 questions, they can think about and evaluate different ways in which they may have coped with stressful events in life. Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.
Measured: Before and after workshop and 24 weeks
Differences in Jefferson Scale of Empathy (JSE) before and after the workshop and Week 24 Assessed
The Jefferson Scale of Empathy (JSE) is to measure empathy in physicians, and other health professionals involved in patient care in a clinical setting; as well as students studying medicine and other forms of health care in preparation for working in a clinical setting. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.
Measured: Before and after workshop and 24 weeks
Differences in Interpersonal Reactivity Index (IRI) before and after the workshop and Week 24 Assessed
The Interpersonal Reactivity Index (IRI) is a published measurement tool for the multi-dimensional assessment of empathy. 28 items using 5-point scales (A = does not describe me well to E = describes me very well) Sub-scales 4 sub-scales, each with 7 items: Fantasy assesses the extent to which individuals identify with fictional characters.
Perspective-taking assesses the extent to which individuals spontaneously (try to) adopt others' points of view.
Empathetic concern assesses the extent of individuals' "feelings of warmth, compassion, and concern for others." Personal distress assesses the extent of individuals "feelings of anxiety and discomfort" as a result of "another's negative experience." scores would range from 28 to 140
Measured: Before and after workshop and 24 weeks
Differences in Maslach Burnout Inventory (MBI) before and after the workshop and Week 24 Assessed
The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout. Scales should not be combined to form a single burnout scale. Maslach, Jackson, and Leiter[1] described item scoring from 0 to 6. There are score ranges that define low, moderate and high levels of each scale based on the 0-6 scoring.
Measured: Before and after workshop and 24 weeks
Differences in Professional Fulfillment Index (PFI) before and after the workshop and Week 24 Assessed
Professional Fulfillment Index (PFI) is a 16-item instrument to assess physicians' professional fulfillment and burnout, designed for sensitivity to change attributable to interventions or other factors affecting physician well-being. All burnout items are scored on a 5-point Likert scale with options ranging from "not at all" to "extremely" for burnout items and "not at all true" to "completely true" for professional fulfillment items. Aggregate scores for burnout and professional fulfillment were calculated using the published approach, with possible scores ranging from 0 to 40 and 0 to 24, respectively.
Measured: Before and after workshop and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start14 May 2020
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-I Wu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964102
- Sponsor's protocol ID
- 20MMHIS092e
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Communication Skills Workshop and Improvements in Stress, Burnout and Empathy and Psychometric Properties of Chinese Version of Perceived Stress Scale, Professional Fulfillment and Burnout Scale and Empathy Among Health Care Professionals
- ClinicalTrials.gov ID
- NCT04964102
- Acronym / sponsor ID
- 20MMHIS092e
- Conditions
- Stress
- Keywords
- Professional burn out, Communication skills, empathy, fulfillment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness and empathy level using data collected in pre and post assessments from "Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills".
Detailed description
The medical community is paying more and more attention to the nature of burnout, physiological, or physical stress of health care professionals (HCP). Burn out and stress not only affects the HCP themselves, but subsequently their team members, medical institutions, and patients. Recent research has found that HCP's stress, burnout, and dissatisfaction with work are associated with their practice time and leaving the job; as well as declines in quality of care, poor patient results, and medical errors.
There seems to be a two-way correlation between burn out and empathy. On the one hand, the more burn out, the lower the degree of empathy; on the other hand, the deficits in perspective substitution seems to be a risk factor for burn out. The increase in multiple perspectives and empathic attention seems prevent burn out. Other studies found that practicing clinical communication skills through practices and role-plays, and using emotional regulation methods to enable participants to express their attitudes and feelings about communicating difficult problems may help HCP improve their degree of empathy and communication skills. When such communication courses add combinations of stress management and social skills training can not only improve communication skills, increase empathy, but also prevent burnout and exhaustion.
Therefore, this study aims to explore associations of burn out, stress, communication skills, interpersonal effectiveness, and empathy level using data collected in pre- and post- assessments from 'Workshops of Enhancing Interpersonal Effectiveness, Emotional Regulation, and Clinical Communication Skills'. Before and after the workshop, information regarding HCP's burn out, perceived stress, empathy level, and interpersonal effectiveness will be assessed in order to understand whether the workshop has reached its goals and teaching effectiveness. All information regarding personal data will be de-identified and encrypted. These assessments are designed to evaluate the effectiveness of teaching activities in a general teaching environment. This study will also focus on the reliability and validity analysis of the short form research measures which used. It will conduct validation studies comparing the Chinese version of the measures which used with internationally well known but long research measures to make sure the reliability and validity. If these shorter forms have well validity, it may be able to use the short and simplified questionnaires for related research in the future.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workshop | Experimental | Behavioral: Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication SkillsWorkshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 20 and 65 years old
- willing to attend the workshop and willing to participate this study
Key exclusion criteria (1 listed)
- age less than 20 or over 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication SkillsWorkshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills | Behavioural | Workshop |
Primary outcome
Change in Perceived Stress Scale (PSS) Score before and after workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
The PSS scores is a rating tool used to gauge the course of stree. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome.
11 secondary outcomes
Differences in Empathy Scale before and after workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Insomnia Severity index (ISI) before and after workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in the State and Trait Anxiety Index (STAI) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Generalized Anxiety Disorder 7-item (GAD-7) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Patient Health Questionnaire-9 (PHQ-9) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Jefferson Scale of Empathy (JSE) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Interpersonal Reactivity Index (IRI) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Maslach Burnout Inventory (MBI) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Differences in Professional Fulfillment Index (PFI) before and after the workshop and Week 24 Assessed
Time frame: Before and after workshop and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills in people with Stress, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) Score before and after workshop and Week 24 Assessed (time frame: Before and after workshop and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.